COVID-19 Global Executive Briefing - Driving Business Continuity April 20, 2020 - IQVIA.com
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COVID-19 Global Executive Briefing Driving Business Continuity April 20, 2020 © 2020. All rights reserved. IQVIA® is a registered trademark of IQVIA Inc. in the United States, the European Union, and various other countries.
Agenda
+ Spread of COVID-19
+ Perspective on COVID-19 treatment paradigm
+ Business impact and continuity for R&D
+ Business impact and continuity for Rx Demand
+ Business impact and continuity for Launch
+ Looking forward
1
COVID-19 Briefing Speakers
Murray Aitken Jeffrey Spaeder, M.D.
Senior Vice President, IQVIA and Chief Medical and
Executive Director, IQVIA Institute Scientific Officer
for Human Data Science
Jeffrey.Spaeder@iqvia.com
Murray.Aitken@iqviainstitute.org
Richard Staub Jon Resnick Alistair Grenfell
President, Research and President, United States President, Europe, Middle
Development and Canada East, Africa and South Asia
Richard.Staub@iqvia.com Jon.Resnick@iqvia.com Alistair.Grenfell@iqvia.com
IQVIA COVID-19 Executive Briefing. © IQVIA 2020. All rights reserved. 2
Rapid expansion
COVID-19 spread rapidly to more than 200 countries with varying national impact
Cases are expanding rapidly worldwide Number of active cases globally (Feb – Future)
As of April 21, 2,402,250 confirmed cases,
163,097 deaths, 213 countries, areas or
territories with cases Assumes continuation of current mitigation strategy.
Interpret with caution.
Source: JHU, CSSE, https://systems.jhu.edu/research/public-health/ncov/, as of April 17, 2020.
Source: WHO, https://www.who.int/emergencies/diseases/novel-coronavirus-2019, as of April 16, 2020.
Source: IQVIA Institute for Human Data Science, AI Dynamic SEIR Model simulates the number of active COVID-19 cases, April 17.
IQVIA COVID-19 Executive Briefing. © IQVIA 2020. All rights reserved. 3
Local variation
Simulations highlight the need to understand local variability
Number of predicted active* COVID-19 Cases per 100k population
Italy US
Assumes continuation of current mitigation strategy. Assumes continuation of current mitigation strategy.
Interpret with caution. Interpret with caution.
*Active cases are those confirmed diagnosed cases, excluded those that have recovered or died.
Source: IQVIA Institute for Human Data Science, AI Dynamic SEIR Model illustrates a simulation of the number of active COVID-19 cases, April 17.
IQVIA COVID-19 Executive Briefing. © IQVIA 2020. All rights reserved. 4
China re-emerges using technology
Indicators show a return of activity, although still isolated
• >90% manufacturing reopened outside Hubei, 49.3% in Hubei
• Pharmaceutical, chemical and electronics industries have recovered
Manufacturing to ～70% of original capacity
• Government has taken actions to stimulate the economy, including low
interest loan, tax subsidy and deferral
Re-opening enabled
• Service sector has recovered to 67% of level seen in 2019 Q4
by significant lock-
nationwide, ~30% in Wuhan
down measures and
Commerce • 90% of supermarkets, retail stores, restaurants and hotels have
re-opened nationwide aggressive digital
tracking and tracing
• Nearly 100% of cross-state highways reopened and 80% local
traffic resumed nationwide
• Other than Wuhan, Hubei unblocked all
Transportation
communities on Mar 18th
Source: National Health Commission IQVIA analysis; Public News
IQVIA COVID-19 Executive Briefing. © IQVIA 2020. All rights reserved.. © IQVIA 2020. All rights reserved. 5
COVID-19 trial progress to date
Significant increase in actual and planned starts since January
Cumulative - Actual Trial Starts, Cumulative - Actual and Anticipated Trial
January 1 – April 1, 2020 Starts, January 1 – April 1, 2020
500 500
450 450
400 400
350 350
300 300
250 250
200 200
150 150
100 100
50 50
0 0
Actual Trial Start Actual and Anticipated Trial Starts
Source: Trialtrove Pharma Intelligence. April 8, 2020; IQVIA Institute. April 14, 2020
Notes: Clinical trials Phase I through IV. Includes interventional trials. Terminated trials were removed. Includes both academic, government, and industry sponsored trials
IQVIA COVID-19 Executive Briefing. © IQVIA 2020. All rights reserved. 6Academics (361)
Federated model to development
Governments (15) Co-op groups (143)
Accelerates timing, albeit creates complexities
Study
Randomized (369) funding
Industry sponsors (105)
Open label
Adaptive (18) (237) Planned (338)
Study
Active (271)
designs
150 Multi-arm (367) Placebo (105)
products Stage
Single arms (69) Real-world
Federated
comparator Approach:
Length of 625 trials Closed /
hospitalization (15) complete (16)
It normally takes a decade, sometimes
even more, to develop a vaccine but
obviously we are in an unprecedented Change in O2
situation, the need is incredibly urgent. saturation (54)
Endpoints
We are partnering with regulators to try US (65)
and go as fast as we safely can."
Emma Walmsley Geography
CEO GSK Mortality (49) China Europe (80)
Pulmonary (305)
Safety (32) function (17)
Source: AdisInsight; Trialtrove Pharma Intelligence. April 8, 2020; IQVIA Institute. April 14, 2020.
Notes: Drugs were counted within programs; Repurposed investigational medicines includes one registrational product. Clinical trials Phase I through IV. Multi-country (515)
Includes interventional trials. Terminated trials were removed. Includes both academic, government, and industry sponsored trials
IQVIA COVID-19 Executive Briefing. © IQVIA 2020. All rights reserved. 7Known targets accelerate R&D
Diverse set of therapies being investigated to treat COVID-19
Starting with what we know
Targets for clinical research Categorization of treatments being pursued:
based upon: Prevention of infection
1. Experience from SARS outbreak o Vaccines
2. Scientific insights specific to o Post-exposure prophylactic therapy for
individuals at high risk
coronaviruses since SARS outbreak
Viral inhibition
3. Downstream inflammatory
pathways o Anti-viral therapies
o Plasma-derived therapy
Immune modulation
o Mitigation of over-expressive immune response
IQVIA COVID-19 Executive Briefing. © IQVIA 2020. All rights reserved..
8Treatment options fit together
Multiple therapies under development offer valuable alternatives
Severity of illness Vaccine for
Serum- population
High risk individuals Immune derived Rx
(Prophylactic treatment) modulation
Viral
inhibition
Symptom
treatment
Patient infected with Immunity
SARS-CoV-2 Mild / Moderate Moderate / Severe symptoms
symptoms
Healthcare providers
(Prophylactic treatment)
Serology testing
IQVIA COVID-19 Executive Briefing. © IQVIA 2020. All rights reserved. 9Regulatory response
Near term regulatory accommodation, potential for permanent paradigm change
• Participant-based risk assessments
General • Urgent safety measures always paramount
• Optimal use of central and remote monitoring programs
Monitoring • Use of remote source data verification
Regulatory
guidance on
conducting
clinical research
• Assessment of what is in best interest of subjects
in setting of Subject rights
• Alternative secure delivery methods
COVID-191 and safety
• Virtual ways of obtaining consent
• Documentation of protocol deviations, missing data and changes in study
conduct
Data integrity and
• Modifications to trial statistical analysis and consequences of missing data
documentation
• Over-communication of all study changes to investigator sites, IRB/ECs
and regulatory authorities
1The MHRA, FDA, EMA, and PMDA have provided consistent guidelines. IQVIA’s guidelines were created in alignment with the principles included in the regulatory guidance.
IQVIA COVID-19 Executive Briefing. © IQVIA 2020. All rights reserved. 10Post COVID-19 clinical needs
Sequelae may create additional, serious medical conditions
Potential long-term
complications of COVID-19
infection may include:
• Heart failure
• Pulmonary fibrosis
• Renal insufficiency
• Exocrine insufficiency
• Neuropsychiatric impact
Source: https://arxiv.org/ftp/arxiv/papers/2003/2003.12773.pdf
IQVIA COVID-19 Executive Briefing. © IQVIA 2020. All rights reserved. 11Broad business impact
Business continuity planning depends on depth and length of disruption
R&D
Rx
demand Launch
IQVIA COVID-19 Executive Briefing. © IQVIA 2020. All rights reserved. 12Quick response to R&D site disruption
Agility is possible with technology infrastructure
% of sites with no CRA visits permitted Virtual Days on Site
EMEA
74% 61%
Remote Days on Site
USA/CAN
USA/CAN APAC
88% 94%
LATAM
APAC
EMEA LATAM
Dec Jan Feb Mar Apr
Source: IQVIA Internal Trial Analysis. Data as of April 14th, 2020
IQVIA COVID-19 Executive Briefing. © IQVIA 2020. All rights reserved.. 13R&D planning adaptation
Virtualization of R&D processes to manage integrity of ongoing trials
R&D planning
to drive
business
continuity
Trial operations Trial design
✓ Initiate digital methods for site ✓ Re-evaluate site and country selection
selection / start-up considering new levers: geographic
✓ Implement remote monitoring impact, technology readiness, built-up
site demand, timing of site access
✓ Execute risk-based monitoring
strategy ✓ Plan for virtual / hybrid trials as site-
less options become possible
IQVIA COVID-19 Executive Briefing. © IQVIA 2020. All rights reserved. 14CASE STUDY
Phase 3
Maintaining R&D momentum Multiple Sclerosis
Adjusting approach for start up activities
Challenge
Maintain site selection momentum during COVID-19
pandemic outbreak
Response
Proactively leverage existing solutions –
~700 sites to be telephonically selected
Remote site training implemented for
immediate enrollment as restrictions lift
120
increase
% Results
After 5 weeks, team is ahead of schedule by 44 sites
Case study is for illustrative purposes only. Results may vary.
IQVIA COVID-19 Executive Briefing. © IQVIA 2020. All rights reserved. 15CASE STUDY
Phase 2b
Rapid response Study Continuity
Patients first approach enabled rapid response to ensure study continuity
Challenge
• Highly complex and challenging study with many assessments
that needed to be conducted at a physical site
• Due to COVID-19, patients cannot travel to sites and sites
2
office-based patient
cannot perform all assessments assessments removed
Response
Protocol simplification – Reassessed the protocol and
removed study activities that were not critical
Patient diaries – Moved to electronic patient reported
outcomes (eCOA) for electronic diary entries
1
week to convert to
Drug delivery and lab assessments – Implemented drug electronic diaries
delivery and home-health services for at-home administration
and lab draws
Results
Remote visits – Pushed to telehealth visits to ensure
continuity of contact between site and patient
47
home visits completed
Rapid response ensured study continuity
IQVIA COVID-19 Executive Briefing. © IQVIA 2020. All rights reserved. 16Broad business impact
Business continuity planning depends on depth and length of disruption
R&D
Rx
demand Launch
IQVIA COVID-19 Executive Briefing. © IQVIA 2020. All rights reserved. 17Rx market slows after initial stockpiling
Fewer visits, less prescribing, more affordability issues
TRx Volume YoY - Italy TRx Volume YoY - US
40 2019 2020 100
95
36
90
Millions
Millions
32 85
80
28
2019 2020
75
24 70
1/13
1/20
1/27
2/10
2/17
2/24
3/16
3/23
3/30
4/13
1/6
2/3
3/2
3/9
4/6
Source: IQVIA National Prescription Audit (NPA). Week ending 4/10 based on Sat-Wed vs prior week retail only
IQVIA COVID-19 Executive Briefing. © IQVIA 2020. All rights reserved. 18Lasting impact of COVID-19
Global trends, US examples
Shift to Physician Affordability
digital strain and access
>1500% 80% >20%
Increase in telehealth claims from Clinicians report “severe” or “close- Increase in copay card claims in
pre-COVID baseline to-severe” financial strain on second week of March vs. 2019
practice
~3-4x 72% ~10 to 25%
Increase in remote detailing from Reduction in Dx visits from pre- Anticipated increase in 2020
baseline, led by specialty COVID baseline, creating significant Medicaid enrollment vs. 2019
healthcare backlog
Source: IQVIA Medical Claims Data, IQVIA National Prescription Audit, IQVIA Formulary Impact Analyzer, IQVIA BrandImpact HCP Network (~3500 unique HCPs)
IQVIA COVID-19 Executive Briefing. © IQVIA 2020. All rights reserved. 19Actions to support ongoing Rx demand
Multiple approaches needed to stabilize Rx demand
Health system support HCP engagement Patient experience
Identify new ways to support health Move forward with proven virtual Reassess and understand the
systems during and post-COVID engagement approaches and plan new patient journey
(e.g., backlog management) for return to in-person detailing
Enhance offerings to support
Explore alternate sites of care for Rethink physician targeting patients through services and
therapy administration and segmentation financial assistance
Accelerate value-based Optimize omnichannel Develop mobile health strategy
evidence demonstration promotion approaches to address patient adherence
and engagement
IQVIA COVID-19 Executive Briefing. © IQVIA 2020. All rights reserved. 20CASE STUDY
Health system
Addressing healthcare system challenges support
Expanding care capacity for COVID patients
Challenge
Virtual care assistant Current HCPs and facilities extremely burdened, unable to
screen or provide care for less severe COVID-19 patients
Response
Developed virtual care solution to:
• Evaluate potential symptoms based on
CDC guidelines
• Enable risk-based escalation to RNs for
additional care assessment as needed
• Allow continued monitoring of those who have
been exposed or diagnosed
Results
Ongoing monitoring Registered Nurses
• Efficient, cost-effective and data-driven approach to
help monitor COVID-19 patients, while also limiting
additional population exposure
IQVIA COVID-19 Executive Briefing. © IQVIA 2020. All rights reserved. 21Remote detailing accelerates
Global markets show varying readiness for e-detailing models
Week of 12 Apr 2019 vs week of 12 Apr 2020 – % Change in absolute recorded promotional volume
600 583 E-detailing and e-meetings
550 Other remote methods (phone, postal, e-mailing)
500 F2F
450
256
% Change
250
200
146
150
100
34 46
50 21 14 2
0
-50 -12
-40 -57
-100 -65 -63 -83 -85 -81 -80
-96
China Korea Italy Japan US Spain France Germany UK
Net change in
promotional
activity
-14% -28% -76% -2% -23% -70% -51% -15% -27%
Source: IQVIA Channel Dynamics, April 12
IQVIA COVID-19 Executive Briefing. © IQVIA 2020. All rights reserved. 22CASE STUDY
Remote
Engagement model changes Detailing
Remote interactions with e-Reps
Challenge
Duration
14 minutes 129 Current COVID-19 situation where medical reps cannot visit
Average duration of the remote Active medical reps; 100 active HCPs face to face anymore
interactions reps per day as an average
Response
5,000 6,000 Quickly implemented technology and training to
KPIS
Remote calls Participants allow medical reps to perform remote detailing calls
to replace their face to face calls
4 calls 30% Results
Of remote calls performed
Per day and per rep
on Monday and 35%
as an average Strong performance on KPIs
between 9 and 11 AM
• After 3 weeks, medical reps have already performed
✓ Platform enables compliant environment 5,000 remote calls (4 remote calls per rep and per day
Key ✓ Change management training critical as an average)
learnings ✓ Focus on patient support, in addition to • 22 contents have been used and 7 contents represent
product and medical information 80% of the usage
*Source: IQVIA BrandImpact HCP Survey
IQVIA COVID-19 Executive Briefing. © IQVIA 2020. All rights reserved. 23CASE STUDY
Providing direct patient assistance EU Response
Pharma call centers to support patients and provide leverage for health systems
Challenge
Original Model
Patients are unable to reach their physicians who have
been called into service for COVID-19 response
Response
Quickly stand-up call centers for patients to call
directly into manufacturer to triage product
questions
New Model
Ensure compliance with EU and local privacy and
regulatory environment
✓ Increase direct connections to patients Results
Key in times of HCP strain
learnings ✓ Proactively evolve patient support beyond 96% patient satisfaction; ongoing efforts to highlight role
Tx initiation to ongoing management of manufacturer as support for patients and health systems
*Source: US IQVIA Case Study MS Call Center
IQVIA COVID-19 Executive Briefing. © IQVIA 2020. All rights reserved. 24Broad business impact
Business continuity planning depends on depth and length of disruption
R&D
Rx
demand Launch
IQVIA COVID-19 Executive Briefing. © IQVIA 2020. All rights reserved. 25Launch segments
Variable demands across launch segments
109
products
50+
products
340+products
Recently launched in 2018-2019 Ready to launch in 2020 Future launch in 2021-2028
• Early stakeholder traction • Approved or filed • Not yet filed
• Field teams in place • Field teams prepped • Finalizing positioning
• Delivering messages • Market shaping in progress • Finalizing launch plans
• Varying challenges in • Medical education in progress • Preparing organization
patient acquisition • Early access discussions
IQVIA COVID-19 Executive Briefing. © IQVIA 2020. All rights reserved. 26Launch disruptions
Neutral long term impact of current launches; yet concern for recent launches
Timeline
Recently Launched Ready to Launch Future Launch
2018-2019 2020 2021-2028
[109 Products] [50+ Products] [340+ Products]
6
4
2
2020-2028
Growth $US (B)
-$10B
0
cumulative
-2
impact
-4 Driven by recent /
current launches
-6 underperformance
-8
2020 2021 2022 2023 2024 2025 2026 2027 2028
Net
impact -3.6B -5.5B -2.6B -1.4B -5.4B -0.3B +5.0B +1.6B +2.1B
Source: IQVIA Institute Analysis
IQVIA COVID-19 Executive Briefing. © IQVIA 2020. All rights reserved. 27Post COVID-19 launch plans
Prioritize launches, drive virtualization to navigate logjam
Re-prioritizing investments across portfolio of launch assets will be critical based on revised market
expectations and product differentiability
FUTURE LAUNCH PRODUCTS READY TO LAUNCH PRODUCTS
• Devise risk mitigation strategies • Make product available, selectively choose
• Develop virtual platforms for to execute full launch activities
engagement • Prepare for asymmetric geographic launch
• Prepare for logjam and focus on • Utilize in market presence to listen and learn
creative approaches to drive
• Execute scalable, virtual solutions; apply a
engagement
local level response RECENTLY LAUNCHED
• Rebalance key in-market activities
(e.g., access, education, market
development)
• Time promotional investment
to access changes and
sensitivities of patients / HCPs
• Tailor programs to patient and
Time Minus Launch Time 0 Launch
community needs
28
IQVIA COVID-19 Executive Briefing. © IQVIA 2020. All rights reserved.CASE STUDY
Virtual Launch
Virtual launch Planning
Agile launch plans to meet stakeholder needs
Challenge
8.5
Small EBP is trying to determine if they should
7.5 launch or wait given environment and limited access
to physicians and patients
6.5
Original launch
Investment
Response
5.5
Virtual thought-leader identification and
4.5
engagement
3.5 New launch with
virtual KOL Integrating omnichannel marketing with
2.5
telehealth data
1.5 Results
Time 1 Time 2
Time
Planned virtual launch given benefit of oral
therapeutic option
IQVIA COVID-19 Executive Briefing. © IQVIA 2020. All rights reserved. 29Moving ahead: What if?
Predefined New approach Fewer large More virtual Global, pan-
sub- to healthcare and in-person patient-HCP healthcare,
populations data meetings interactions collaborations
Create consistency for Plan for new data, Adapt to new ways to Supplement Manage new rules,
more value study privacy approaches, share scientific, in-person visits approaches, and risks
comparisons analytic capabilities commercial insights (e.g., Dx, compliance) across parties
IQVIA COVID-19 Executive Briefing. © IQVIA 2020. All rights reserved. 30Appendix
31Disclaimer The analyses, their interpretation, and related information contained herein are made and provided subject to the assumptions, methodologies, caveats, and variables described in this report and are based on third party sources and data reasonably believed to be reliable. No warranty is made as to the completeness or accuracy of such third party sources or data. As with any attempt to estimate future events, the forecasts, projections, conclusions, and other information included herein are subject to certain risks and uncertainties, and are not to be considered guarantees of any particular outcome. IQVIA reserves all rights relating to reproduction, quotation, broadcasting and publication. No part of this presentation may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopy, recording, or any information storage and retrieval system, without express written consent of IQVIA. Copyright © 2020 IQVIA. All rights reserved. IQVIA® is a registered trademark of IQVIA Inc. in the United States and various other countries. IQVIA COVID-19 Executive Briefing. © IQVIA 2020. All rights reserved. 32
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